Multimodalitic Imaging in the N-stage of Lung Cancer

Peking University

Status: Not yet enrolling

Conditions: Neoplasm of Lung

Treatments: Drug: 18F-FDG; Procedure: EBUS-TBNA; Device: MR STIR

Study type: Interventional

Funder types: Other

Identifiers

NCT05840094

LCN001

Details and patient eligibility

About

This study aims to evaluate the diagnostic efficacy and differences between 18F-FDG PET/CT and MR STIR sequences combined with EBUS-TBNA, 18F-FDG PET/CT combined with EBUS-TBNA, and MR STIR sequences combined with EBUS-TBNA - three types of multimodal imaging for assessing NSCLC N-stage, in order to select the best assessment protocol to guide treatment decisions and prognostic assessments.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Biopsy pathologically confirmed NSCLC, or clinically highly suspicious NSCLC (assessed as highly suspicious by the MDT team of this study);
• N1, N2, or N3 confined to the mediastinum and hilum, as assessed by imaging;
• Proposed systematic lymph node dissection without any treatment;
• Appropriate laboratory tests (serum tumor markers);
• All examination intervals ≤ 4 weeks;
• KPS score ≥ 50 (ECOG/WHO equivalent);
• Aged > 18 years; 8. Patients can fully understand and voluntarily participate in this trial and sign the informed consent; the examination can be completed independently.

Exclusion criteria

• Contraindication to EBUS-TBNA operation;
• Presence or history of other malignancies within 10 years;
• Inability to understand the examination procedure or to cooperate.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

PET/CT+MR+EBUS

Experimental group

Description:

Subjects will receive 18F-FDG PET/CT and MR STIR sequence combined with EBUS-TBNA, to diagnose the N-stage of NSCLC

Treatment:

Device: MR STIR

Procedure: EBUS-TBNA

Drug: 18F-FDG

PET/CT+EBUS

Experimental group

Description:

Subjects will receive 18F-FDG PET/CT and EBUS-TBNA, to diagnose the N-stage of NSCLC

Treatment:

Procedure: EBUS-TBNA

Drug: 18F-FDG

MR+EBUS

Experimental group

Description:

Subjects will receive 18F-FDG PET/CT and EBUS-TBNA, to diagnose the N-stage of NSCLC

Treatment:

Device: MR STIR

Procedure: EBUS-TBNA